First Cell Culture Based Vaccine Plant in the United States

By on December 16, 2011

Earlier this week, Novartis announced that their plant in Holly Springs, North Carolina had received Federal approval for the production of influenza vaccines. The one billion dollar facility is the first of its kind in the United States, dedicated to using cell culture techniques to manufacture vaccines instead of the 50 year old conventional egg based technology. This plant joins several European facilities that have already received approval for cell culture based vaccine manufacturing.

The plant is the result of a 25-year public/private partnership between Novartis and the US Department of Health and Human Services (USHHS). In an earlier blog titled “In preparation for the next pandemic,” the Cell Culture Dish discussed the new Novartis facility and the manufacturing improvements to be gained from utilizing cell culture for vaccines. In 2005-2006, USHHS awarded contracts to five companies to improve current vaccine technology and build cell culture based vaccine facilities, of the five Novartis is the only company who carried through and opened a cell culture based plant.

There are several advantages to using a cell-based manufacturing system for vaccines. With cell culture, production begins as soon as a virus strain is identified; there is no need to engineer the virus to grow in eggs. This can cut weeks off total manufacturing time. Officials at USHHS have already mentioned the possibility of using this plant and cell culture based vaccine manufacturing for vaccines against known and emerging infectious diseases. The use of this technology will not be limited to the flu, but could be applied if other pandemics arise. Cell based production also allows manufacturers to increase production quickly and produce more vaccine when compared to egg based technology. USHHS officials have stated that the new Novartis facility could produce up to 25% of the country’s vaccines in the event of a pandemic.

“Today we’re marking the first change in influenza vaccine manufacturing in the United States in 50 years,” said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR). Robinson led the effort for HHS. “The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases.”

In the previous blog, I asked, “So are we prepared for the next pandemic?” and I still don’t think that we know the answer. However, facilities like the one in Holly Springs certainly provide USHHS and the Centers for Disease Control more options and more flexibility than relying on egg based production.

One Comment

  1. Blog Reader

    12 January, 2012 at 10:22 AM

    The advantage of cell based influenza production for the rapid development pandemic vaccines is huge. Cell based production reduces the potential problem of low titers of pandemic strains from eggs. For example, the low titers of H5N1 from eggs caused a problem that limited the number of available doses of vaccine. The first H5N1 vaccines were limited to half the amount of typical antigen. Often, low titer can be overcome by “egg adapting” the strain. However, this approach has drawbacks since there is a possibility that the vaccine many acquire altered antigenicity during the adaptation process.

    Novartis uses their proprietary MDCK cell line that is also used for production of the Optiflu seasonal vaccine in Europe. Interesting, MDCK is not (yet) an FDA approved cell substrate for vaccine production because of its tumorigenic potential. Baxter’s alternative approach in Europe is to utilize Vero cells as a production substrate for their Celvapan pandemic vaccine(H1N1). Vero cells have been approved as a cell substrate by the EMA and FDA for numerous vaccines.

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